Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

High-Sensitivity Troponin in the Evaluation of Patients With Acute Coronary Syndrome (High-STEACS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University of Edinburgh
Sponsor:
Collaborators:
NHS Lothian
NHS Greater Glasgow and Clyde
Abbott Diagnostics Division
Information provided by (Responsible Party):
University of Edinburgh
ClinicalTrials.gov Identifier:
NCT01852123
First received: April 29, 2013
Last updated: July 1, 2014
Last verified: July 2014
  Purpose

In patients with chest pain the diagnosis of a heart attack (myocardial infarction) is made where there is evidence of heart muscle damage using a blood test to measure the heart muscle protein troponin. A new a more sensitive troponin test may help us to identify patients with myocardial infarction more easily.

The investigators propose to evaluate whether use of a novel high-sensitivity troponin test to lower the threshold for diagnosis of myocardial infarction is appropriate. If increased sensitivity does not reduce specificity for the diagnosis, then this new test will improve patient outcome through better targeting of therapies for coronary heart disease. However, if increased sensitivity leads to poor specificity, then patients may be misdiagnosed and given inappropriate cardiac medications with potentially detrimental outcomes.

In ten secondary and tertiary care hospitals across Scotland, the investigators will undertake a stepped wedge cluster randomized controlled trial of the implementation of a novel high-sensitivity troponin test. The primary end-point will be the one-year rate of cardiovascular death or recurrent myocardial infarction. This will establish whether the introduction of this high-sensitivity troponin test into routine clinical practice is beneficial to patient management and outcomes.

A subset of patients will be asked to give consent for inclusion into a sub-study that will permit storage of blood samples and will require the completion of a survey during the index admission and after 6 and 12 months of follow up.


Condition Intervention
Acute Coronary Syndrome
Myocardial Infarction
Device: High-sensitivity troponin I assay

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: High-Sensitivity Troponin in the Evaluation of Patients With Acute Coronary Syndrome: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Edinburgh:

Primary Outcome Measures:
  • Recurrent myocardial infarction or cardiovascular death at 1 year [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of stay [ Time Frame: Initial episode ] [ Designated as safety issue: No ]
    Duration of the index hospital stay, an expected average of 2 weeks

  • Recurrent myocardial infarction [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Unplanned coronary revascularization [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Cardiovascular death [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • All cause death [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Heart failure hospitalization [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Major hemorrhage [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Minor hemorrhage [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Recurrent unplanned hospitalization excluding acute coronary syndrome [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Non-cardiovascular death [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Physician diagnosis on discharge [ Time Frame: Duration of the index hospital stay, an expected average of 2 weeks ] [ Designated as safety issue: No ]
  • Sensitivity and specificity of sex-specific thresholds for the diagnosis of myocardial infarction [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 23800
Study Start Date: May 2013
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Early implementation
The high-sensitivity troponin I assay will be implemented after a 6 month validation phase
Device: High-sensitivity troponin I assay
Other Name: ARCHITECT STAT high-sensitive troponin I assay
Late implementation
The high-sensitivity troponin I assay will be implemented after a 12 month validation phase
Device: High-sensitivity troponin I assay
Other Name: ARCHITECT STAT high-sensitive troponin I assay

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Suspected acute coronary syndrome
  • Troponin I measurement as part of routine clinical care

Exclusion criteria:

- None

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01852123

Contacts
Contact: Fiona Strachan, PhD f.strachan@ed.ac.uk

Locations
United Kingdom
Royal Infirmary of Edinburgh Recruiting
Edinburgh, Lothian, United Kingdom, EH16 4SB
Principal Investigator: Nicholas L Mills, MD, PhD         
Sponsors and Collaborators
University of Edinburgh
NHS Lothian
NHS Greater Glasgow and Clyde
Abbott Diagnostics Division
Investigators
Principal Investigator: Nicholas L Mills, MD, PhD University of Edinburgh
Study Chair: Ian Ford, PhD University of Glasgow
  More Information

No publications provided

Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT01852123     History of Changes
Other Study ID Numbers: High-STEACS, SP/12/10/29922
Study First Received: April 29, 2013
Last Updated: July 1, 2014
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Edinburgh:
High-sensitivity troponin assay
Myocardial infarction
Unstable angina
Myocardial injury
Cluster randomized trial

Additional relevant MeSH terms:
Acute Coronary Syndrome
Infarction
Myocardial Infarction
Syndrome
Angina Pectoris
Cardiovascular Diseases
Chest Pain
Disease
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pain
Pathologic Processes
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on November 19, 2014